FREQUENTLY ASKED QUESTIONS (FAQ)
Clinical laboratory licensing and registration
Of physician office laboratories or clinics
Laboratory Field Services
Department of Health Services
1111 Broadway Street, 19th Floor
Oakland, CA 94607
http://www.dhs.ca.gov/ps/ls/lfsb/default.htm
Contact information:
Bea O’Keefe, bokeefe@dhs.ca.gov, (510) 873-6361
Shiu Land Kwong, skwong1@dhs.ca.gov, (510)-873-6405
Karen Nickel, knickel@dhs.ca.gov, (510) 873-6360
QUESTION
What is a clinical laboratory?
Would a physician office laboratory
(POL) be considered a clinical
laboratory?
Why do clinical laboratories need to
be licensed or registered?
What is the difference between
laboratory licensure and registration?
Are there some laboratories that are
exempt from licensure or
registration?
What about POLs? Are they
excluded from licensure or
registration requirements?
What type of facility is considered a
POL in California law?
Is there any benefit in California to
be classified as a POL?
ANSWER
A clinical laboratory is defined in state and federal law
as any place where testing is done on human
specimens for diagnostic purposes.
Yes, a POL is considered a clinical laboratory if any
patient testing is done, as urine dipstick tests, fingerstick
blood tests or Pap smear review and reporting, for
example.
The law requires it. Licensing and registration of clinical
laboratories helps assure that quality standards are
maintained in clinical laboratories. Licensure or
registration is part of the process that may include
inspections, complaint review, proficiency testing
oversight, and so on.
Laboratories doing non-waived testing need to be
inspected and licensed. Laboratories doing waived or
provider-performed microscopy only need to be
registered, although some waived laboratories may also
be inspected.
A few types of laboratories are excluded from this
requirement, as veteran’s hospitals, public health
laboratories, forensic laboratories, and research or
teaching laboratories.
No, POLs must be licensed or registered.
A POL is a group of 5 or fewer physicians who do
testing only on their own patients, do not perform any
testing for other physicians, do not perform HIV testing
or review Pap smears.
A POL may employ any competent person to do testing
in their office laboratory. Testing persons do not need to
be state licensed, but must meet federal requirements
and be supervised by a physician.
Is it true that if my office qualifies as
a POL and needs to get a state
license that I don’t have to hire
licensed clinical laboratory scientists.
That’s right. A POL that meets the definition above and
that is licensed, does not need to employ licensed
testing personnel. A POL would need to meet all
laboratory license requirements, however.
Our POL has been paying CLIA fees
for many years. Why do we have to
pay fees to the state, also?
Clinical laboratories in California are subject to two kinds
of regulations—state and federal. Federal CLIA fees go
to CMS which is responsible for assuring all laboratories
in the US comply with federal standards. State license
or registration fees support the state program which is
responsible for making sure all laboratories in California
comply with state standards. There are many ways that
state and federal standards differ, so the two systems
are necessary.
I hear there are similarities between
There are important differences between state and
state and CLIA standards. Why can’t federal law. Clinical laboratories in California have had
one system be used in California?
to comply with standards enacted in state law since
What do I gain from double systems? 1926 and ongoing. If the state relied on federal
standards only, many of these laws would be ignored.
This would have an adverse impact on public health.
Is there any way that California can
Yes, but it is difficult. California must prove to the
eliminate federal law and fees for
federal government that all laboratories in California
clinical laboratories?
comply with federal standards, and that the state can
assure ongoing compliance. This is called “CLIA
exemption” and was attempted and abandoned in 1996.
I have never paid fees to the state
The Department of Health Services has decided to
before. What is different now that we again pursue CLIA exemption to eliminate federal
have to start paying laboratory fees? oversight in California. In order to do that, it must make
sure that all laboratories comply with state law, and that
state law is at least as strict as federal law.
How long will this whole process
It will take several years for all laboratories in California
take?
to be licensed or registered and then CLIA exemption,
which eliminates federal fees, will be sought.
When do I have to apply for
If your laboratory is required to be licensed or
licensure or registration?
registered, you will be notified by the Department of
Health Services. You do not need to contact the
Department of Health Services.
Are there some laboratories which
Yes, if your laboratory has been operating unchanged
do not need to be licensed or
with a valid CLIA certificate since January 1, 1996, your
registered right away?
CLIA certificate continues to serve as your state
registration or license until regulations are changed,
sometime in 2006.
Why was licensure or registration
delayed for these laboratories?
Emergency regulations were passed during an attempt
to gain CLIA exemption in 1996. This allowed a CLIA
certificate to serve as a state license or registration
temporarily until CLIA exemption was achieved. In order
to apply for CLIA exemption now, all laboratories in
California must be licensed or registered to ensure they
comply with state law.